Monday, September 16, 2019

Sharpless may seal FDA commissioner nomination before November deadline

After orchestrating a series of moves to help cancer patients, the FDA’s acting commissioner appears to be on the inside track for a permanent appointment to the post

FDA commisioner Ned Sharpless photographed while he served Director fo the National Cancer Institute | Photo By NCI
This month, more than 50 patient advocacy organizations delivered a letter to President Trump requesting that Dr. Ned Sharpless be nominated and confirmed to lead the FDA on a permanent basis.

Sharpless, a cancer researcher who previously served as head of the National Cancer Institute, was appointed as acting FDA commissioner in March. Under federal law, he can only continue in that capacity until November 1st unless he is nominated to serve permanently.

During his tenure, Sharpless has been proactive in helping people with cancer who are seeking access to experimental treatments.

In June, he announced that the agency would provide “concierge service” to oncologists navigating the agency’s burdensome process for requesting use of unapproved drugs. And last month, at the urging of The Abigail Alliance, the FDA suggested crucial improvements to the use of placebos in cancer trials. 

While Sharpless has earned some support with his laser-focus on oncology, advocacy groups for people with other diseases are withholding final judgment until the end of this month, when the FDA releases a long-overdue guidance document for the development of therapies to treat Amyotrophic Lateral Sclerosis (ALS). 

Last month, several delays in the document’s release prompted Navy veteran and ALS patient Matt Bellina to threaten a hunger strike. Within 24 hours, dozens of other people with ALS (pALS) vowed to join Bellina in refusing food and water.

Sharpless quickly agreed to finalize the long-overdue guidance by the end of September.

Thousands of pALS have requested that the final document encourage companies to utilize the new right to try law and the agency's compassionate use program to provide experimental therapies to patients who don’t qualify for late-stage clinical trials. They also hope that the FDA will ask drug companies to provide pALS access to experimental treatments after they participate in clinical trials.

“We have worked well with Dr. Sharpless and his team and hope that we can continue to build on this initial progress going forward to create a truly impactful set of reforms to help ALS patients now,” said Brian Wallach, a former Obama staffer who co-founded I AM ALS after being diagnosed with the disease last year.

“However, we are all waiting on the final Guidance to see how much progress we have actually made,” he concluded.

If Sharpless is ultimately appointed to head the FDA permanently, he will be following a similar path as Commissioner Andrew von Eschenbach, who ran the agency from 2006 to 2009.

After serving as NCI director, von Eschenbach was named acting FDA Commissioner in September 2005. He was confirmed by the Senate as the permanent commissioner in December 2006. 

During von Eschenbach’s time at the FDA, The Abigail Alliance mounted a serious legal challenge to the agency’s unnecessary restrictions on terminally-ill patients’ access to experimental treatments.

Though the court of appeals ruled against the notion of a constitutionally-protected right for terminally-ill patients to try investigational medications, the arguments made in the lawsuit formed a basis for the right to try movement.